{"id":"pimecrolimus-active-cream","safety":{"commonSideEffects":[{"rate":"10-25","effect":"Application site burning or irritation"},{"rate":"5-15","effect":"Pruritus"},{"rate":"5-10","effect":"Skin infection (secondary bacterial or viral)"},{"rate":"2-5","effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL1200686","moleculeType":"Small molecule","molecularWeight":"810.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pimecrolimus binds to calcineurin and inhibits its phosphatase activity, preventing the dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of pro-inflammatory cytokines such as IL-2, TNF-α, and IFN-γ, thereby reducing local immune activation and inflammation in atopic dermatitis and other inflammatory skin conditions.","oneSentence":"Pimecrolimus is a calcineurin inhibitor that suppresses T-cell activation and inflammatory cytokine production in the skin.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:42:00.341Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis (eczema)"},{"name":"Mild to moderate atopic dermatitis in pediatric and adult patients"}]},"trialDetails":[{"nctId":"NCT02103725","phase":"PHASE1","title":"A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2014-04","conditions":"Atopic Dermatitis","enrollment":30},{"nctId":"NCT05729074","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients","status":"UNKNOWN","sponsor":"HK inno.N Corporation","startDate":"2023-02-13","conditions":"Mild to Moderate Atopic Dermatitis","enrollment":80},{"nctId":"NCT00403559","phase":"PHASE2","title":"A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis","status":"COMPLETED","sponsor":"Dermatology Specialists Research","startDate":"2007-05-07","conditions":"Seborrheic Dermatitis","enrollment":113},{"nctId":"NCT03539601","phase":"PHASE4","title":"A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD","status":"TERMINATED","sponsor":"Pfizer","startDate":"2018-04-27","conditions":"Atopic Dermatitis","enrollment":237},{"nctId":"NCT02791308","phase":"PHASE3","title":"Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2015-02","conditions":"Atopic Dermatitis","enrollment":587},{"nctId":"NCT03297502","phase":"PHASE3","title":"Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2016-06","conditions":"Atopic Dermatitis","enrollment":582},{"nctId":"NCT00507832","phase":"PHASE2","title":"Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease","status":"COMPLETED","sponsor":"University Hospital Muenster","startDate":"2007-04","conditions":"Prurigo Nodularis","enrollment":30},{"nctId":"NCT00810862","phase":"PHASE4","title":"Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children","status":"TERMINATED","sponsor":"Children's Hospital of Michigan","startDate":"2006-11","conditions":"Atopic Dermatitis","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Elidel 1% cream Novartis Pharmaceuticals"],"phase":"marketed","status":"active","brandName":"pimecrolimus active cream","genericName":"pimecrolimus active cream","companyName":"Children's Hospital of Michigan","companyId":"children-s-hospital-of-michigan","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pimecrolimus is a calcineurin inhibitor that suppresses T-cell activation and inflammatory cytokine production in the skin. Used for Atopic dermatitis (eczema), Mild to moderate atopic dermatitis in pediatric and adult patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}